- BioAgilytix (Durham, NC)
- …data integrity and compliance.Develop a roadmap for building a high-performing data management team, identifying roles in data engineering, quality , and ... That means hands-on work designing Azure Data Factory and API integrations, automating data- quality checks, and setting up clear governance so everyone knows who can… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …validation, and reconciliation, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements that adhere to ... reconciliation reports, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements. Oversees the execution… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regulated applications meet strict regulatory requirements, industry best practices, and internal quality standards. The Lead is responsible for defining and ... Digital Transformation (DX) strategy, regulatory compliance framework, and overall quality assurance standards. This role collaborates with cross- functional … more
- Genmab (NJ)
- …we would love to have you join us!The RoleThe Associate Director, External Data Quality Management , is a strategic leadership role within Clinical Data ... vendor management a plus.Proven expertise in protocol design, data quality management , and protocol deviation oversight.Strong knowledge of EDC systems,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …educational materials and initiatives related to quality concepts across global teams. Lead and inspire cross- functional QA teams to implement effective data ... PV QA) and is a member of the leadership team. Lead an enterprise cross- functional QA team to... standards in ongoing projects and processes.Coordinate with the Quality Management System (RDPVMA) teams to support… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …experienced quality representatives and/or contingency workers. Essential Functions Deviation Management Develops and serves as Quality Point of Contact for ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....and inspections Demonstrate leadership skills via acting as project lead on cross- functional projects in the development… more
- Aequor (Thousand Oaks, CA)
- …of equipment in area of expertise. 15. Extensive knowledge and application of SAP Quality Management (QM) Module 16. Advanced skills in solving complex problems. ... management . 4. Work within the Information Services and Quality Systems teams to foster good communication throughout the...both orally and in writing. 20. Initiate, coordinate and lead cross functional team. 21. Excellent skill… more
- Eisai, Inc (Raleigh, NC)
- …plans to meet the demand forecast. The Director, Western SCM Unit will lead a cross- functional team driving excellence in Import/Export Compliance, Logistics, ... to hear from you. The Director Western Supply Chain Management (SCM) Unit is accountable and/or responsible for providing...the demand forecast. The Director, Western SCM Unit will lead a cross- functional team driving excellence in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and the development of group members. This position also monitors trends in functional performance via quality , time, and cost indicators, and develops plans ... Data Management globally and ensures execution of the global data management strategy across regions and across studies/programs. Lead DM resource model… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …levels and from different disciplines and cultures. This position requires demonstrated line management experience and the ability to manage/ lead people and a ... processes in support of clinical development objectives.- Accountable for lab data management deliverables for all programs meeting quality and time expectations… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …within a matrixed global teams environmentMust have a broad understanding of quality management system, GxP regulations and industry trend/practiceMust have ... and GxP training across DS group including business units, functional units and corporate functions. Lead Training function...Lead Training function team and Document and record management function team to enhance training and document and… more
- Merck & Co. (Durham, NC)
- …expenses and improve quality without compromising superior customer service. FUNCTIONAL EXPERTISE: Lead in the identification and implementation of process ... The site includes an Energy Center, Fill Finish Manufacturing Facilities, Quality Labs, various other manufacturing buildings and Maintenance and Material Storage… more
- Merck & Co. (Durham, NC)
- …their primary support facility (ie Sterile Supply, Lyophilization, and Filling) and cross- functional teams (ie Tech Ops, Maintenance, Quality , Automation, and ... contracted validation partners. Prioritize team safety, environmental, and compliance objectives. Lead , facilitate, and participate on cross- functional teams to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …related experience within the Pharmaceutical industry is required Proven ability to lead cross- functional teams to achieve a shared goals Outstanding planning ... and new product commercialization assets (3 years prior to launch). They will lead the development and implementation of brand plans, development of capabilities to… more
- Merck & Co. (Rahway, NJ)
- …including both performance and talent management activitiesProven leadership and project management skills to lead cross functional teams, drive ... functional teams.-Ensures project results meet requirements regarding technical quality , reliability, schedule, and cost.Monitors performance and recommends schedule… more
- Merck & Co. (Rahway, NJ)
- … lead , work, and collaborate in internal and external cross- functional , matrixed teams.Problem Solving:-Remove roadblocks, resolve conflicts, and escalate issues ... Process Development, Engineering Standards, Estimation and Planning, Maintenance Supervision, Management Process, Manufacturing Quality Control, Manufacturing Scale-Up,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …mitigation strategies and process improvements to stakeholders via the QMS framework (ie, Quality Management Review, Quality Review Board) across the global ... Specialty Medicine portfolios, in alignment with the business strategy Lead the DSG inspection management activities by... management in close collaboration with the organization's quality management system, to assure robust knowledge… more
- Merck & Co. (Rahway, NJ)
- Job Description Lead the Future of Biologics Drug Substance Commercialization! Are you a bold, strategic thinker with a passion for biologics? We're looking for a ... Biologics Science & Technology (S&T) portfolio. In this high-impact role, you'll lead the Drug Substance Working Group (DSWG), mentor scientific talent, and partner… more
- Merck & Co. (Durham, NC)
- …business. Primary Responsibilities and Activities include but are not limited to : Lead an Integrated Cross- Functional Team in Delivery of Reliable and Compliant ... Source Changes, Technical Transfers, Equipment Maintenance, Reliability, and Lifecycle Management ). Lead Periodic Business and Operations Review Meetings… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …supported by timely, accurate and cost-effective data and analysis. Viewed as a functional expert in this field by internal and external stakeholders. Guide cross ... functional portfolio teams on analytics and market research approach...ultimately improve commercial and clinical planning Design, execute and lead all capability benchmarking projects in support of ET… more
